Analytical Specificity of Bladder EpiCheck Test in Healthy Population and Urology Patients Without Prior History or Evidence of Bladder Cancer

Completed

Conditions studied: Non Muscle Invasive Bladder Cancer, Non-Muscle Invasive Bladder Urothelial Carcinoma

In brief

This is a prospective study to establish the analytical specificity of Bladder EpiCheck test in urine samples from healthy population and urology patients without prior history or evidence of bladder cancer.

Key facts

Study ID

NCT06020807

Run by

Nucleix Ltd.

People needed

168

Starts

2019-09-05

Expected to finish

2020-01-08

Last updated by the study team

2023-09-07

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 22 or older
• Able to sign the informed consent form
• Normal, healthy subjects or subjects with one of the following conditions:
• Benign non-genitourinary disease (e.g. heart disease)
• Non-genitourinary cancers (e.g. lung, CRC, breast)
• Genitourinary disease other than bladder cancer including:
• Benign prostatic hyperplasia (BPH)
• Microhematuria proven negative for bladder cancer through prior UCC evaluation
• Inflammation/infection
• Symptomatic sexually transmitted disease (STD)
• Urinary tract stones
• Genitourinary trauma
• Subjects with native bladder

You may not qualify if…

• Known current or prior diagnosis of bladder cancer (non-muscle or muscle invasive)
• Currently in work-up due to suspicion of cancer of any kind

Where it is running

• Urology San Antonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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